Title: Alternative Sweeteners

Sucralose 197
Table 2 Sucralose Interaction Study: Sucralose Retention (%) After 7 Days at 40°C
Sample pH 3.0 pH 4.0 pH 5.0 pH 7.0
Control 100 99.8 98.9 99.5
Sucralose and hydrogen peroxide 100 99.7
Sucralose and sodium metabisulfite 99.9 99.9
Sucralose and acetaldehyde 100 100
Sucralose and ethyl acetoacetate 98.8 100
Sucralose and ferric chloride 95.9 98.0
Sucralose and niacinamide 100 100
Sucralose and monosodium glutamate 99.8 100
technique. Table 2 shows the sucralose retention in each of the solutions. As can
be seen from the data, there are no chemical interactions of concern. These data
demonstrate that sucralose is chemically inert, and therefore chemical interactions
of sucralose with ingredients in formulations are not likely to occur.
G. Stability of the Ingredient
Stability of the dry pure sucralose, as well as the aqueous solutions of sucralose,
have been evaluated to determine the shelf life and proper storage and distribution
conditions for the ingredient. Because of the physicochemical characteristics and
the inherent stability of the molecule in aqueous solution, two forms of the ingredient,
dry and a liquid concentrate, are available.
H. Stability of Dry Neat Sucralose
The stability of dry neat sucralose has been measured at several temperatures to
assess the shelf life and the storage conditions required to properly store and
distribute this form of the ingredient. The first indication of the breakdown of
neat sucralose is the development of a mild discoloration (tan/pink), which is
accompanied by a very small release of HCl. The development of color occurs
before the detection of a loss of sucralose by HPLC analysis. Time and temperature
conditions that have impact on the appearance of slight color change have
been shown to be affected by packaging materials and container head space. The
mild discoloration is a quality issue, and proper storage of dry sucralose is necessary
to ensure that sucralose will be of the proper quality for its incorporation
in products.
As an example, dry neat sucralose was sealed in glass vials, stored at 75°F
(23.8°C), 86°F (30°C), 104°F (40°C), and 122°F (50°C), and monitored for the
development of color. The time to first discoloration was 18 months at 75°F; 3
months at 86°F; 3 weeks at 104°F; and less than 1 week at 122°F. As these data